—#179704

Product

BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

FDA product code: PQK — Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K182796
Affected lot / code info: Product Code: W04200 Lot/Serial Number: S0053

Why it was recalled

The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 04/12/2019, the firm sent an "Urgent Medical Device Recall Notification" to its customers to inform them the firm has become aware that the WavelinQ 4FEndoAVF System, Product Code W04200, Lot Number S0053 may be at risk of experiencing a magnetic deficiency between the venous and arterial magnetic catheters, which may result in the magnets failing to attract to one another. The firm is instructing customers to remove any affected inventory from use and provided instructions to its customers to take regarding this product. The firm is requesting its customers to complete the required actions and fill out the Recall and Effectiveness Check Form to confirm the quantities and lot numbers of each recalled products intended to be returned. Email the completed Recall and Effectiveness Check Form to BPV.CustomerSupportCenter@crbard.com or fax it to BPV at 1-800-994-6772. For additional questions, customers are instructed to call the BPV Customer Support Center at 1-800-321-4254 Option #5. On 04/26/2019, a second communication "Urgent Medical Device Recall Notification" letter was sent to each of the US consignees via FedEx with proof of delivery notification. The letter explained the firm's records showing the customer purchased one or more units from the affected lot. The 2nd notice was send to confirm receipt of this recall information. Firm's records indicated they have not received all returned inventory from the customer. The firm's corrective action plan is still being developed. A field action is also in process of being initiated for affected lot of an equivalent product sold outside the US (EverlinQ 4F EndoAVF System). The equivalent product is not approved or sold in the US.

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Bldg 1, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: US Nationwide distribution in the states of NY, TN, TX, FL, NC, GA, NH, MO, CA, SC, AL, IL, VA, IN. No US Gov. Consignees No OUS Consignees for the WavelinQ 4F EndoAVF System. However, a field action is in process of being initiated for affected lot of an equivalent product sold outside the US (EverlinQ 4F EndoAVF System). The equivalent product is not approved or sold in the US.

Timeline

Recall initiated: 2019-04-12
Terminated: 2021-07-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179704. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.